Job Description
Join BioVita Innovations, a leading biopharmaceutical pioneer in cutting-edge therapies. We seek a dynamic Senior Clinical Research Associate to drive our next-generation oncology trials. Collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and patient safety while advancing life-changing treatments. Enjoy competitive compensation, comprehensive benefits, and a culture of scientific excellence.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring GCP/ICH compliance
- Monitor site performance, conduct site visits, and resolve protocol deviations
- Manage clinical documentation (eCase Report Forms, regulatory submissions)
- Liaise with FDA, IRBs, and internal stakeholders for trial approvals
- Analyze trial data and prepare safety/reports for regulatory authorities
- Mentor junior CRAs and optimize clinical trial workflows
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or related field (Master's preferred)
- 5+ years clinical research experience with oncology focus
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in FDA/ICH-GCP regulations and clinical trial management
- Strong data management and auditing skills (e.g., Medidata Rave)
- Exceptional communication and problem-solving abilities
- Ability to travel up to 40% domestically